Clinical Trial Manager
The Clinical Trial Manager is accountable for ensuring clinical trial activities and deliverables are completed on-time, within budget, and in a highly dynamic and complex environment in accordance with appropriate quality standards including GCP/ICH requirements and Nektar SOPs. This position will manage essential duties and responsibilities as independently as possible, with guidance and oversight provided by the clinical program Director when needed. This job contributes to and supports the company’s research and development efforts to create high value therapeutics to address unmet medical needs.
Oversee and manage all aspects of a clinical trial in accordance with Nektar SOPs, ICH/GCP regulations and study-specific manuals and procedures. Lead Study Management Team(s), including cross-functional team(s), CRO(s) and third-party vendors as applicable. Develop and manage effective relationships with key study stakeholders. Responsible for key study quality metrics (i.e., eligibility, primary endpoint data, etc.). Assist in identification, evaluation and hiring of appropriate CROs and other third party study vendors in accordance with Nektar SOPs. Management of CROs and other third party vendors, including setting expectations, training, managing timelines and deliverables, and issue management. Provide input to the clinical study budget and responsible for managing assigned vendor budget(s). In collaboration with the Study Management Team, identify risks to study and develop risk mitigation plans, including communication with senior management when necessary. Write or contribute to preparation of clinical protocols, informed consent forms, study manuals, case report forms, and other clinical research related documents. Ensure clinical data are reviewed in accordance with study data review plans and that a final, clean dataset is provided upon database lock. Project and coordinate study supply and packaging requirements. Manage expert consultant activities for study related activities, including effective communication. Identify program/resource gaps and proposes solutions. Provide weekly enrollment and program updates to senior management. Identify and share best practices and process improvements with colleagues to ensure optimal efficiency and consistency in Clinical Operations. Lead or participate in functional initiatives and/or activities as assigned. May mentor and develop junior clinical operations staff.
A Bachelor’s degree or equivalent is required (life science degree is preferred). Typically 8 years pharmaceutical development experience with at least 2 years overseeing trial management is required. Strong experience working as a Clinical Research Associate is preferred and thorough knowledge of clinical monitoring practices is required. Must have demonstrated problem solving abilities and strong organizational skills. Excellent written and verbal communication skills are required. Strong computer skills (MS Office) are required. Excellent working knowledge of FDA & ICH GCP regulations and guidelines is required. Must be a demonstrated self-starter and team player with strong interpersonal skills. Must possess excellent cross-functional clinical project management skills. Demonstrated ability to develop and implement SOPs and Study Plans. Fluent English is required.